National Academies skeptical at Best.

If you would like to watch the IOM conference you can check out day one here
My take away from the first day.

"Do you guys (DTC) know what you are doing?"

"I wonder what kind of research and the quality you can provide?"

"I can't believe you aren't regulated already."

I think there are some really big issues here and there is some confusion.
Questions that remain to be answered..........
1. "Will these companies sell the customer/patient DNA/data?"
2. "Are these companies practicing medicine?"
3. "How do we quantify personal utility?"
4. "Will regulation really kill these companies?"
5. "What rigors and hoops will be required for these companies with research?"
6. "What will the GAO find about today's DTC companies?"

The best thing these companies have done is raise the need for answers and refined regulations.

The worst thing these companies have done is put customers/patients at risk for
1. genetic theft
2. harm via untrained physician
3. false predictions and false hopes
4. 3rd party harm

These companies should be behaving more responsibly, it is sad that they continue to market deceptively. It is also sad that they have not more carefully thought out their research aims. They clearly don't care about the chain of trust.

The Sherpa Says: I think the IOM and National Academies are skeptical at best. Which is the right attitude IMHO. DTC has a lot to prove and it hasn't done anything to do that yet.

IOM not webcast today. Why Not?

The IOM conference "Direct-to-Consumer Genetic Testing: A Cross-Academies Workshop" will not be webcast today? I wonder why not? Was it supposed to be and then submarined after Muin Khoury quoted an email I wrote him while he was presenting?

Why is there no webcast for this important conference today?

Maybe I am just a conspiracy theorist.

But I would like IOM and the National Academies to explain why the cover one day but not the second.

The second day by the way has some great topics


From the Agenda

Session 5: The Impact of DTC Genetic Tests on the Medical System

"If the medical system is no longer required to mediate genetic testing, how will the system cope with losing oversight (and reimbursement) of these services while retaining the full responsibility of caring for patients the services affect?"

Here is a little hint. Currently there is no mediation of this DTC testing, therefore you can see what is happening. Marketing hype, misinformation, inaccurate results, improper provision of the results, lack of follow up, no post services offered to BRCA mutation carriers.

Here's a mind bender, can you bill insurance legally for a ICD9 of Genetic Susceptibility to Breast Cancer from a 23andMx test for a 99245 on a HCFA form? Or is that insurance fraud?

To let these types of tests out in the wild, which we have, is only to introduce a lot of chaos which is not for the "Better" it is actually dangerous to the patient.

Now Back to the Agenda:

"Issues to Address:

Can we model the cost to the medical system of DTC genetic testing?

Reimbursement and DTC genetic testing – are insurance companies involved?
Do they have a role?

How can providers navigate DTC testing and results for patients in the clinic?

How do consumers react to DTC testing information, and what is the impact on their health behavior?"

Well, I would love to hear the explanations, but alas there is no webcast today!

Back to the Agenda

"Knowledge of DTC Genetic Testing Among the Public and Health Professionals"

I wonder if the public read the NY Times article yesterday ?

"It’s important to separate hope from hype,” Dr. Jennifer House, president of the March of Dimes, said at a recent meeting of its national communications advisory council. “Direct-to-consumer genetic testing is a buyer-beware market. Consumers need to be very, very cautious.”

Uh......haven't I been saying that for 2 years now? A little late to the sh!t party huh Dr House?

"At the moment, the reliability of most gene tests on all four criteria is questionable, Dr. Dolan said, adding that the “broad landscape of direct-to-consumer genetic testing is a slippery slope.”

You go Siobhan! Yet another one of Dr Marion's prodigies!

Yet, what Dr Khoury et.al. found is that 75% of doctors who were presented in the office with one of these DTC tests ALTERED care in some way.

What do Healthcare practitioners know about genetics? Very Little. What does the public know? Even Less. Which is why they are such an easy target to market to.

Back to the Agenda

"Cooperation or Competition – How Do Health Care and DTC Genetic Testing Coexist?"

They don't. Someone asked the guy from Pathway Genomics yesterday

"Do you think you are practicing medicine? If not, why not?"

That is the question here. Tell me Navi, 23andSergey, Pathway.........why aren't you practicing medicine?

You take a human biological sample, perform a test, run an algorithm and give a risk for disease. In what world is that not medicine?

Let me guess. "Uh we do those things, but what makes us NOT medicine is that we.....uh......
We uh...........we uh....DON'T CLAIM LEGAL RESPONSIBILITY FOR OUR ANSWERS"

The Sherpa Says: The IOM conference is going to be predictable, unless Google has dumped money into the Academies or the IOM......

National Academies and the IOM

Today and Sept. 1 the National Research Council and Institute of Medicine will hold a symposium to explore the health, policy, and ethical implications of direct-to-consumer genetic testing

AUDIO WEBCAST: Morning sessions on Aug. 31 -- covering the history and likely evolution of direct-to-consumer genetic testing, as well as the regulatory framework -- will be available via live audio webcast at http://national-academies.org.

Don't miss this. I am listening to Muin Khoury right now.

BTW, the best question was just asked. "Do you think you are practicing medicine and if no, explain why not?"

That is the crux of this whole DTC field. I have always thought, they are.......

The Sherpa Says: I will cover this and the NIH conference over the week.